Senior Study Start-Up Specialist

该职位负责临床试验启动阶段的全流程协调与管理，包括伦理审查、监管提交、合同谈判等，需要3年以上SSU经验及良好沟通能力

Key Accountabilities: SSU Coordination and Execution: Coordinates, guides, and assists with all start up activities prior to site activation, including but not limited to: Site Informed Consent Form (“ICF”) localization and guidance in line with regulatory/health authority requirements. Ethics Committee (“EC”) information, meeting dates & costs. Ethics applications & associated online systems. Ethics & Governance submission processes. Clinical Trial Health Authority application and regulatory submission process. Contracts & Indemnity request process. For global studies, localize global ICF with country requirements. Local sample application and permit submission processes. Maintains up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation. Reviews, analyzes, and collates metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation. Ensures all start up information & requirements are kept up to date in a central repository for both global and local study teams. Assists with label preparation and approval (local label representative) for studies in collaboration with local regulatory department. Tracks metrics and SSU timelines to identify trends and opportunities for improvement. Relationship management: Liaises and collaborates with relevant authorities/bodies to further enhance clinical trial processes, government policies/laws, via innovative approaches. Maintains current, and awareness of changes in, startup processes across government, hospital & industry & liaises with stakeholders to resolve any SSU issues. Proactively responds to information survey requests by government/ industry bodies. Provides continuous and proactive communication with ECs/hospital administration/industry bodies to obtain accurate and up to date information on clinical trial status and activities. Maintains communication with local legal/regulatory/clinical operation to ensure input is sought and all internal/external requirements are met. Provides guidance to Country Study Managers (CSMs) and Country Study Specialist (CSS) on regulatory/ethics, tracks & drives site activations by regular review and monitoring status of submissions/ activations. Collaborates with vendor management and procurement to provide input as required into vendor identification, selection, and Request for Information (RFI)/ Request for Proposal (RFP) process. Liaises and shares best practices with other SSU within the region/organization. New Site Identification: Assists with identification and tracking of new sites in collaboration with CSMs. Performs/coordinates site level feasibility activities including evaluation of patient population and final site selection. Contracts/ Budget: Negotiates contracts and study budgets with sites during the SSU phase to ensure finalization. Provides local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country. Collaborates with CSMs to maintain data to ensure FMV. Liaises with management/CSMs to implement budget cost containment and implement contingencies as required. Compliance with Parexel standards: Complies with required training curriculum. Completes timesheets accurately as required. Submits expense reports as required. Updates CV as required. Maintains a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements.